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Re: foxhound02 post# 443988

Monday, 02/14/2022 11:44:16 PM

Monday, February 14, 2022 11:44:16 PM

Post# of 700461
Trying to dig a deep den, the fox hits rock just beneath the surface. Be gone with you animals of the hunt, and make way for the Mardi Gras parade rolling on in. Everybody’s dancing and there are fireworks, calliopes and even some clowns.

You do not have to make a filing public and FDA leaves that to a company to decide. You do have to make a rejection public and quite often it is due to not adequately preparing commercial manufacturing or its quality assurance. That is where a lot of companies get tripped up.
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